Otowave 202 Portable Tympanometer— 510(k) K150163

Substantially Equivalent

Amplivox, Ltd.

FDA 510(k) clearance K150163 for Otowave 202 Portable Tympanometer, Substantially Equivalent on 2015-04-23. Applicant: Amplivox, Ltd..

Clearance details

Applicant: Amplivox, Ltd.
Product code: Code NAS
Advisory panel: Ear, Nose, Throat
Date received: 2015-01-26
Decision date: 2015-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eynsham, GB

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